Subconjunctival Bupivacaine in Strabismus Surgery

Not Applicable

• Conditions: Anesthesia, Local
• Interventions: Drug: Placebo; Drug: Iocal anaesthetic bupivacaine

• Registration Number: NCT04782960
• Lead Sponsor: Fayoum University

Brief Summary

This study aimed to assess the effectiveness of the Subconjunctival bupivacaine on postoperative pain in Strabismus surgery under general anaesthesia.

Detailed Description

40 patients will schedule for elective Strabismus surgery under general anaesthesia and randomly allocated into two groups to receive Subconjunctival 0.5%Bupivacaine group(B) or Subconjunctival placebo 0.9% normal saline group at the end of the surgery and assess the postoperative pain at 0th,30th, 60th,2nd h, 4h,6h,12h,24h.and post operative nausea and vomiting.

Study Timeline

• Study First Submitted: 2021-02-16
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Study First Posted: 2021-03-04
• Last Update Posted: 2021-03-04
• Study Start: 2021-04
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• All patients aged 14 _30 years old with body mass index 18_28kg/m.
• American Anaesthesiologist Association physical states I,II.
• singed informed consent to participate in the study and were scheduled for strabismus operations under general anaesthesia.

Exclusion Criteria

• were patients with chronic pain.
• ocular hypertension.
• inability to communicate.
• history of hematological disease.
• allergy to local anesthetic drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20 patients receive Subconjunctival placebo in the end of operation	Placebo	20 patients receive Subconjunctival placebo in the end of operation and monitoring postoperative pain score
20 patients receive Subconjunctival bupivacaine of the end of the surgery	Iocal anaesthetic bupivacaine	20 patients receive Subconjunctival bupivacaine in the end of operation and monitoring postoperative pain score

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS) pain score	5 minutes after extubation	Range, 0_10;0,no pain ;10,worst pain

Secondary Outcome Measures

Name	Time	Method
Nausea and vomiting	24 hours postoperatively	Operation related side effect